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Trial Details
Trial status:
In follow-up (non-recruiting)
Recruitment start date:
12/04/2016
Funder:
Cancer Research UK
Sponsor:
UCL
Chief Investigator:
Dr Gillian Whitfield
Recruitment target:
84
EudraCT number:
Contact details:
ctc.hippo@ucl.ac.uk
Lay summary:
HIPPO
A randomized phase II trial of Hippocampal Sparing versus Conventional Whole Brain Radiotherapy after surgical resection or radiosurgery in favourable prognosis patients with 1-4 brain metastases
Description
Design: HIPPO is a 1:1 randomised multicentre phase II study investigating Hippocampal Sparing Whole Brain Radiotherapy (HS-WBRT) versus standard Whole Brain Radiotherapy (WBRT) after neurosurgery or stereotactic radiosurgery (SRS) in patients with 1-4 brain metastases. Patients are randomised 1-4 weeks from neurosurgery/SRS. The primary endpoint is the Hopkins Verbal Learning Test – Revised (HVLT-R) at 4 months from completion of radiotherapy, and a battery of other neurocognitive function (NCF) assessments make up the majority of the secondary endpoints. 
Treatment: Patients receive 30 Gy in 10 fractions over 2 weeks as either HS-WBRT or standard WBRT, beginning 4-6 weeks from the date of neurosurgery/SRS. Patients are followed up for 2 years from the completion of radiotherapy at 2, 4, 6, 9, 12, 18 and 24 months. NCF is assessed at each time point except 9 and 18 months. 
Key inclusion/exclusion criteria: Patients >16 years with brain metastases from a systemic malignancy which have been histologically confirmed. These must have been treated by neurosurgery or SRS. Patients must be able to complete the NCF test battery. Patients with metastases from small cell carcinoma from any site, haematological malignancy, or central nervous system malignancy are excluded.
Duration of recruitment: 3 years. 
Aim
To determine whether HS-WBRT reduces decline in NCF compared to WBRT in patients with 1-4 brain metastases after neurosurgery or stereotactic radiosurgery (SRS). HIPPO will also help to determine whether it is feasible to conduct a Phase III randomised trial of HS-WBRT in the UK. 
Trial protocols
Trial protocols must not be applied to patients treated outside trials. UCL CTC can only ensure that approved trial investigators are provided with amendments to protocols.
No protocols have been currently made available for download
Trial documents
No documents have been currently made available for download
Contact Us
Cancer Research UK & UCL Cancer Trials Centre
University College London
90 Tottenham Court Road
London
W1T 4TJ

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Email:
ctc.enquiries@ucl.ac.uk
Telephone:
+44 (0)20 7679 9898 (General CTC Enquiries)
Fax:
020 7679 9899
University College London, Gower Street, London, WC1E 6BT +44 (0)20 7679 2000

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